ANGIOJET ULTRA AVX THROMBECTOMY SET
FDA 510(k) clearance K133629 · decided 2014-02-14
Clearance details
- K-number
- K133629
- Device name
- ANGIOJET ULTRA AVX THROMBECTOMY SET
- Applicant
- Possis Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-11-26
- Decision date
- 2014-02-14
- Days to decision
- 80 days
- Clearance type
- Special
- Product code
- QEW
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Possis Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylen recall (Z-2380-2015) | Boston Scientific Corporation | 2015-08-13 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| POSSIS PERMA-SEAL DIALYSIS ACCESS GRAFT (P980017/S001) | Possis Medical, Inc. | 1999-03-24 |
| PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20 (P980017) | Possis Medical, Inc. | 1998-09-25 |